Posts Tagged ‘National Cholesterol Education Program’

When the FDA is deciding on the approval or rejection of a new drug or medical device, they often call upon medical experts from around the country. This practice is an excellent way for the agency to tap into the vast amounts of knowledge from leading experts. Theoretically, it’s a great system that ensures patients and physicians get safe and effective medicines.

But, in recent years the FDA has had difficulty in recruiting these advisors. In 2008, the FDA enacted a policy preventing scientists with financial ties to pharmaceutical, biotech and medical device companies from serving on FDA Advisory Committees. The rationale for this policy was pretty simple: any scientist or physician who had advised a biopharmaceutical company might feel obligated to support that company’s position when reviewing one of their drugs or medical devices. The FDA wanted advisors with uncompromised views.

These conflict-of-interest rules developed from events that occurred in the previous decade. One notable example was the issuance of new guidelines for lowering LDL cholesterol by the National Cholesterol Education Program (NCEP), a division of the government’s National Heart, Lung and Blood Institute. The NCEP recommended that all people should have an LDL level no higher than 100 mg/dL and that those patients at high risk for a heart attack and/or stroke should reduce their LDL levels to 70. “Heart officials urge sharply lower cholesterol levels” heralded The New York Times (July 12, 2004). Forbes focused on another aspect of the new guidelines: “Cholesterol Guidelines a gift for Merck, Pfizer” (July 12, 2004) – a clear reference to the fact that the two biggest selling LDL lowering drugs, Zocor and Lipitor, were sold by these companies.

However, concerns about these guidelines arose when people realized that the NCEP panel that made these recommendations was made up largely of physicians who had been paid as consultants or who had been involved in the clinical trials of the very same drugs that would now be used more extensively. Consumer groups and others began to challenge whether these panelists had the ability to act in the public’s best interests. While this example focuses on the NCEP Guidelines, similar examples were cropping up in other disease areas as well. As a result, the FDA began to use advisors with minimal industry ties. This measure is now proving to be an obstacle in the FDA’s recruiting process.

Pharmaceutical companies draw heavily upon experts for a variety of reasons. These experts are in demand to lead or to play a part in running clinical trials for a company’s major new drugs. These same experts are sought to comment on clinical design strategies, or to provide advice on new breakthroughs in understanding diseases. These scientist/physicians are even sought to participate in “mock advisory committee meetings” that a company will have to prepare for a real FDA Advisory Committee hearing. When companies do this, they will always try to get the leaders in the field. These leaders can and do command high fees for their services, and these fees preclude them from advising the FDA.

Part of the problem also comes from the natural progression of drug discovery and development. The clinical studies are obviously done way in advance of the filing of a New Drug Application (NDA). Thus, many experts are “conflicted” long before there is even the possibility of scheduling an FDA Advisory meeting to review an NDA. When you consider that there are many companies working in every therapeutic area and that the pool of experts is finite, it’s no wonder that the number of people left for the FDA to choose from is pretty small.

A few months ago, FDA Commissioner Margaret Hamberg told a congressional committee that the FDA will seek to loosen the conflict-of-interest rules in 2012. She testified that: “We have to be sure that FDA has subject-matter experts that we need for our important decision making” (Bloomberg, 7/25/2011). Just last week, three Senators (Klobuchar, MN.; Burr, NC; Bennet, CO) proposed legislation that would loosen the conflict-of-interest rules for FDA advisors (Reuters, 10/13/11). A similar bill is anticipated from the House of Representatives.

These changes will help the FDA in recruiting advisors. But the changes will not be embraced. Be prepared for a host of consumer groups to decry these efforts with claims that the FDA is again cozying up to Big Pharma and seeking advice from biased scientists and physicians. Once again, the FDA is stuck in the middle. But the system is workable. To be effective, all FDA advisors will need to have complete disclosure with whatever ties they have to commercial entities. In addition, complete financial disclosures of the payments they have received will need to be available to afford complete transparency. In fairness, many physicians already do this. Finally, at some point we need to trust these physicians and scientists to do the right thing, that they will advise the FDA based on scientific data and not their corporate affiliation. I think the medical community is more than able to handle this responsibility ethically.